A Phase II Study of Tucatinib and Trastuzumab Followed by Chemotherapy as Initial Treatment for Locally Advanced HER2-Positive Rectal Cancer


Full Title

A Phase II Study of Induction Tucatinib and Trastuzumab with Total Neoadjuvant Therapy for Locally Advanced HER2-amplified Rectal Adenocarcinoma


This study is assessing the safety and effectiveness of giving tucatinib and trastuzumab followed by standard CAPOX chemotherapy (the drugs capecitabine and oxaliplatin) in people with locally advanced rectal cancer that has not yet been treated and makes a protein called HER2. Tucatinib and trastuzumab both block HER2, which stimulates cancer cell growth.

Researchers think that trastuzumab and tucatinib, when taken together, followed by CAPOX may be a more effective treatment for HER2-positive rectal cancer than the usual chemotherapy medications alone. Tucatinib and capecitabine are taken orally (by mouth) and trastuzumab and oxaliplatin are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have locally advanced rectal cancer that makes the HER2 protein.
  • Patients’ cancers must have a normal KRAS gene.
  • No prior rectal cancer treatment is permitted.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.


For more information and to ask about eligibility for this study, please contact the office of Dr. Andrea Cercek at 646-888-4189.




Phase II (phase 2)

Disease Status

Relapsed or Refractory


ClinicalTrials.gov ID